K191435 is an FDA 510(k) clearance for the IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4. This device is classified as a Stimulator, Peripheral Nerve, Implanted (pain Relief) (Class II - Special Controls, product code GZF).
Submitted by Nalu Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 6, 2019, 99 days after receiving the submission on May 30, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5870.
| 510(k) Number | K191435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2019 |
| Decision Date | September 06, 2019 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZF - Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5870 |